Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109069
Recruitment Status : Enrolling by invitation
First Posted : April 22, 2010
Last Update Posted : April 4, 2018
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics LLC.

Brief Summary:
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diffuse Well-differentiated Lymphocytic Lymphoma B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma Non-Hodgkin's Lymphoma Waldenstrom Macroglobulinemia Burkitt Lymphoma B-Cell Diffuse Lymphoma Drug: PCI-32765 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia.
Study Start Date : June 2010
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: PCI-32765 Drug: PCI-32765
Dose based on parent protocol

Primary Outcome Measures :
  1. Adverse Events/ Safety Tolerability [ Time Frame: 30 days after last dose of study drug ]
    Frequency, severity, and relatedness of adverse events

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Frequency of tumor assessments done per standard of care ]
    Tumor response will be assessed per established response criteria. This study will capture time to progression-free survival

  2. Duration of Response [ Time Frame: Time to disease progression ]
    Duration of response as measured by established response criteria for B cell lymphoma and chronic lymphocytic leukemia

  3. Overall Survival [ Time Frame: Every 3 months (±7 days) until the end of study ]
    After disease progression, attempts to follow for subject survival status (including cause of death) by clinic visit, or phone contact as well as collection of subsequent anti cancer therapy should be performed once every 3 months (±7 days) until the end of study.

  4. Tolerability [ Time Frame: 30 days after last dose of study drug ]
    Long term tolerability as measured by treatment related SAEs and discontinuation of study treatment due to AEs.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
  • Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Exclusion Criteria:

  • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
  • Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
  • Lactating or pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01109069

United States, California
Stanford University
Stanford, California, United States, 94305
Stanford, California, United States, 94305
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, New York
New Hyde Park, New York, United States, 11042
New York, New York, United States, 10065
Rochester, New York, United States, 14642-0001
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Oregon
Springfield, Oregon, United States, 97477
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Houston, Texas, United States, 77030
Tyler, Texas, United States, 75702
United States, Vermont
Fletcher Allen Health Care and University of Vermont
Burlington, Vermont, United States, 05405
United States, Washington
Vancouver, Washington, United States, 98684
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pharmacyclics LLC.
Janssen Research & Development, LLC
Study Director: Zahid Bashir, MD Medical Monitor

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pharmacyclics LLC. Identifier: NCT01109069     History of Changes
Other Study ID Numbers: PCYC-1103-CA
PCI-32765 ( Other Identifier: Pharmacyclics )
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Pharmacyclics LLC.:
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, B-Cell
Bruton's Tyrosine Kinase

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Burkitt Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders